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Vaccines, Blood & Biologics

Re-evaluation of proposed proprietary name Hizentra BLA STN: 125350 - Hizentra, February 22, 2010




Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Date:February 22, 2010
From:Lisa L. Stockbridge., Regulatory Review Officer
Advertising and Promotional Labeling Branch (APLB) (HFM-602)
Division of Case Management (DCM)
Through:Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, (HFM-602)
To:Hon-Sum Ko, Medical Officer, OBRR/DH/CRB. HFM-392
Pratibha Rana, Regulatory Project Manager, OBRR/DBA/RPMB, HFM-380
Subject:Re-evaluation of proposed proprietary name Hizentra
BLA STN: 125350
Recommendation:Hizentra proprietary name be found Acceptable

Executive Summary

APLB has performed a re-evaluation of the proposed proprietary name Hizentra to determine if any new products have been approved since our previous review on June 9, 2009 (please see EDR for complete review memo).  APLB found that no new products have been approved that would change our previous recommendation.  APLB recommends that the proposed proprietary name Hizentra be found Acceptable.

Proposed Proprietary Name Evaluation

APLB re-reviewed the proprietary name to ensure that our review is within 90 days of approval.  The PDUFA goal date for this original BLA is February 26, 2010.

Hizentra will be marketed by CSL Behring (CSL). Currently, Vivaglobin is the only other immune globulin product approved for subcutaneous use, and it is marketed by CSL. There were no newly marketed products whose names resembled Hizentra from a potential look-alike or sound-alike perspective.


APLB recommends that the proposed proprietary name Hizentra be found acceptable at this time.  No recently approved products whose names resemble Hizentra were found.

Reference used (CDER New Drug (NDA and BLA) Approvals) through 2/10/10); searched 2/22/10

Firm name: CSL Behring
Letter type: Memorandum
File name:   Hizentra PNR 90 day reeval_22Feb10.pdf 

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